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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

When it comes to legislation and regulation, word choice matters greatly. As any lawyer who specializes in constitutional law can tell you, the inclusion of a single seemingly inconsequential word can mean the difference between a policy that stands the test of time and one that is subject to endless argument.

And when it comes to a new draft policy proposed by the European Medicines Agency (EMA) that would increase clinical trials transparency in the EU, the inclusion of just one word has industry officials crying foul.

Background

EMA has been moving toward a policy of transparency since at least November 2010, when it first announced its intent to eventually publish all research data provided to it in support of a regulatory dossier or application. The plan kicked into high gear in July 2012, when reports emerged that EMA was formally developing the plan, which it did in June 2013.

That plan has won rave reviews from some transparency advocates, including those behind the&nbsp;AllTrials&nbsp;campaign, which is campaigning for the release of all clinical data. Industry, however, has been far less supportive, with at least two-AbbVie (formerly of Abbott Laboratories) and InterMune-suing&nbsp;the agency to stop it from releasing what they called "commercially confidential information."

Those arguments evidently held enough weight with the General Court of the EU to merit an interim order barring the agency from publishing its transparency plan, at least for the time being.

In the meantime, EMA has been moving forward with plans to allow select access to the contested documents on a "case-by-case" basis, and has continued to debate the issue with industry.

Recently, two industry groups, US-based PhRMA and the EU-based European Federation of Pharmaceutical Industries and Associations (EFPIA), released their own data transparency plan, favoring a model that allows select access to data on a case-by-case basis. That model, they said, would balance the ability to conduct research with the need for patient privacy and the ability to protect commercial information from foreign and domestic competitors.

'Full' of Problems: EFPIA

But with its own plans now out for public consumption, EFPIA has moved into attack mode. In comments released on 5 September 2013, the group took strong issue with EMA's choice of words in its proposal.

"I have some serious reservations about [this policy]," wrote EFPIA General Director Richard Bergstr&ouml;m in a blog post.

"To make a very long story short, I'd like to point to a single word," Bergstr&ouml;m continued. "In line 15 of the EMA policy, are written the words, 'There is a growing demand for full transparency from certain external stakeholders in the debate...'"

The key word there, he adds, is full, as in full transparency. This contrasts with the PhRMA/EFPIA policy, which calls for only partial transparency.

The question, then, is one of sufficiency. Is a clinical transparency policy sufficient if it is not fully transparent, or could it meet the threshold by releasing partially redacted data? Bergstr&ouml;m calls for "responsible or appropriate transparency" to "best improve access to clinical trials data while taking into account the need to protect public health."

Three Main Issues for Industry

According to EFPIA, full transparency "carries real dangers" with respect to three factors:

patients, whose data could be de-identified

regulatory systems, which could see the weight of their decisions discounted by misread data

research, which EFPIA argues would lack the incentive for investment if other companies knew they could simply mooch off the efforts of others

"By employing terminology and conditions which are too broad, the EMA draft Policy suggests a lack of protection of commercial confidential information (CCI) that not only threatens incentives to innovate, but also comes into conflict with EU law," EFPIA wrote in an accompanying executive summary of its comments to EMA.

What remains to be seen, however, is whether EFPIA's comments will weigh on the minds of regulators. Some, including EMA's Chief Medical Officer Han-Georg Eichler, have aggressively pushed for full transparency measures, arguing that full transparency is in the best interest of patients, whom he argues the pharmaceutical industry ultimately works for.

"I hope everybody will learn that daylight is the best disinfectant and this will be a contributing step in rebuilding trust in the regulator and in the industry," Eichler told&nbsp;Reuters in July 2012.

Can sunlight still disinfect with clouds in the sky? Industry will have to hope EMA thinks so.